Top 63 Regulatory affairs manager Jobs in Florham Park Nj

Associate Manager, Regulatory Affairs
Exeltis & Xiromed —Florham Park, NJ
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Writing skills
Quick Apply
7d
Manager/Senior Manager, Global Regulatory Affairs
Menarini Group —New York, NY
- $135,000 - $180,000 a year
- Bachelor of Science
- Office
- Bachelor's degree
- Health savings account
- AD&D insurance
Manager, Regulatory Affairs - Tactical Implementation
Insmed Incorporated —Bridgewater, NJ
- $133,000 - $173,000 a year
- Full-time
- Remote
- Microsoft Outlook
- 5 years
- Bachelor's degree
- Employee stock purchase plan
- Disability insurance
Manager, Regulatory Affairs - China
Fresh —Jersey City, NJ
- $100,000 - $140,000 a year
- Full-time
- Office
- Master's degree
- Bachelor's degree
- Commuter assistance
- Paid parental leave
Regulatory Affairs Manager
TRIPLECOM —New Brunswick, NJ
- Office
- 3 years
- Bachelor's degree
Regulatory Affairs Project Manager (173814)
Colgate-Palmolive —Piscataway, NJ
- $124,000 - $174,000 a year
- Hybrid work
- Master's degree
- Bachelor's degree
- Travel
- Profit sharing
- Paid parental leave
Senior Regulatory Affairs Specialist
OrganOx —Madison, NJ
- $120,000 - $137,000 a year
- Full-time
- Hybrid work
- 5 years
- Continuous improvement
- Travel
- Paid holidays
- Disability insurance
Quick Apply
10d
Senior Manager / Associate Director, Regulatory Affairs CMC
Shionogi Inc. —Florham Park, NJ
- $140,000 - $200,000 a year
- Email
- Hybrid work
- Microsoft Excel
- 5 years
- Office
Project Manager, Regulatory Affairs - Project Management
Aleon Pharma International, Inc. —Parsippany-Troy Hills, NJ
- $70,000 - $80,000 a year
- Email
- Hybrid work
- 11+ years
- Mid-level
- US work authorization
- Health insurance
- Dental insurance
Quick Apply
Manager Regulatory Affairs
Breckenridge Pharmaceutical Inc —Berkeley Heights, NJ
- $120,000 - $165,000 a year
- Full-time
- 8 years
- Analysis skills
- Bachelor's degree
- Health insurance
Quick Apply
Manager, Regulatory Response
Google —New York, NY
- $211,000 - $293,000 a year
- Full-time
- Office
- Supervising experience
- Bachelor's degree
- Paid holidays
- Disability insurance
4d
Manager, Project Management, Regulatory
Legend Biotech US —Somerset, NJ
- $110,706 - $145,303 a year
- Full-time
- Microsoft Excel
- Mid-level
- Master's degree
Quick Apply
14d
Manager/Director Board Governance & Executive Affairs
The Fedcap Group —New York, NY
- $85,000 - $130,000 a year
- Full-time
- Hybrid work
- Project management
- Bachelor's degree
- Travel
Manager-CMC Manager- Regulatory Affairs
Genpact —Jersey City, NJ
- Temporary
- Senior level
- Leadership
- Communication skills
Regulatory Affairs Program Manager
ImmunityBio —Summit, NJ
- $141,300 - $157,000 a year
- Full-time
- Office
- Analysis skills
- Bachelor's degree
- AD&D insurance
- Disability insurance
US Regulatory Affairs Senior Manager – Allergy
Opella Healthcare Group —Morristown, NJ
- $127,500.00 - $184,166.66 a year
- Full-time
- Hybrid work
- Bachelor's degree
- Doctor of Philosophy
- Mentoring
11d
Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)
AbbVie —Branchburg, NJ
- $124,500 - $236,500 a year
- Full-time
- Hybrid work
- Doctor of Philosophy
- Team management
- Experience equivalent to degree accepted
- Paid holidays
- Health insurance
6d
Manager, Regulatory Affairs Packaging Compliance
Bath & Body Works —New York, NY
- $107,000 - $182,600 a year
- Full-time
- Hybrid work
- Office
- Bachelor's degree
- Mentoring
- Store discount
- Paid parental leave
12d
Manager, Regulatory Affairs Strategy - Oncology
Regeneron —Warren, NJ
- $128,600 - $210,000 a year
- Medicine
- Office
- Doctor of Philosophy
- Health insurance
- Dental insurance
Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins - Hybrid
AbbVie —Florham Park, NJ
- $124,500 - $236,500 a year
- 8 hour shift
- Hybrid work
- Doctor of Philosophy
- Experience equivalent to degree accepted
- Senior level
- Paid holidays
- Health insurance

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Associate Manager, Regulatory Affairs

Exeltis & Xiromed
Florham Park, NJ

Quick Apply

Job Details

Full-time
7 days ago

Qualifications

Microsoft Excel
Database systems
Microsoft Outlook
Team leadership
E-filing platforms
English
Bachelor's degree
Microsoft Teams
SharePoint
Adobe Acrobat
General management

Full Job Description

Role Overview

The Associate Manager, Regulatory Affairs supports the planning, preparation, submission, and maintenance of regulatory filings to ensure compliance with applicable health authority requirements. This role works closely with cross-functional teams, including Quality, R&D, Manufacturing, Pharmacovigilance, Medical Affairs, Supply Chain, and other technical functions to support product development and lifecycle management, with a focus on original ANDA submissions for complex generic products, including inhalation and/or drug-device combination products. The Assistant Manager helps ensure that regulatory strategies are executed effectively and that documentation is accurate, complete, and submitted within required timelines. This role is best suited for a candidate with a strong interest in technically challenging products and regulatory strategy for complex generics.

Primary Duties & Responsibilities

Support the Associate Director of Regulatory Affairs in executing regulatory strategies for original ANDA submissions, with emphasis on complex drug dosage forms, including inhalation and/or drug-device combination products.
Prepare, compile, review, and submit regulatory dossiers, variations, renewals, amendments, and other regulatory filings in accordance with applicable regional and global requirements.
Maintain and update regulatory documentation for marketed products and pipeline products.
Monitor submission timelines and ensure regulatory deliverables are completed on schedule.
Coordinate with internal cross-functional stakeholders to collect, review, and organize required documents and data for submissions.
Track regulatory commitments, agency correspondence, and approval timelines.
Assist in responding to health authority questions, deficiency letters, and requests for additional information, particularly for technical and CMC-related topics.
Support the preparation and review of technical regulatory content for complex generic products including inhalation and/or combination products.
Provide regulatory input on development activities involving formulation, analytical, manufacturing, and device-related considerations, as applicable.
Stay informed on current regulatory requirements, guidance documents, and industry trends relevant to complex generics, inhalation products, and combination products.
Participate in internal meetings and provide regulatory input to support project planning and decision-making.
Contribute to process improvement initiatives within the Regulatory Affairs function.
Ensure all activities are conducted in compliance with company policies, quality standards, and applicable regulatory requirements.

Additional Duties & Responsibilities

Process documents, prepare, assemble, compile and publish regulatory submissions in Electronic Common Technical Documents format (eCTD) as required.
Support the review and organization of submission components to ensure technical accuracy, completeness, and consistency across dossiers.

Competencies/Career level

Innovation, entrepreneurial attitude, customer orientation, team leadership, adaptability/flexibility, results-oriented, control of budgets/costs, Self-development.

Requirements and personal skills

Education: Bachelor’s Degree (Life Science preferred)
Languages: English
Experience (years/area): 6
Specific Knowledge: FDA regulations, and guidance; experience with original ANDAs preferred; experience with complex generic products, especially inhalation and/or drug-device combination products, strongly preferred.
Travel: Minimal
Personal skills: General management skills, strong interpersonal and people development skills, strong results-orientation, superior leadership skills, ability to anticipate problems and solve them successfully.
Proficiencies: Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams, SharePoint); Adobe Acrobat; database systems; eCTD Compilation software

Physical Demands

This job operates in a professional environment. This role routinely uses standard office equipment such as computers, phones, printers, etc.

Travel: Some overnight travel may be needed for this position. There may be occasional local day travel.

Position Type and Expected Hours of Work: This is a full-time position. Days and hours of work are Monday through Friday, 9:00 a.m. to 5 p.m.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee:

Is required to interact with internal and external contacts independently
Is regularly required to talk or hear either in person or over a dial tone phone, as well as a mobile phone, when applicable.
Is often required to stand, walk, bend, lift, or sit.
Is required to occasionally lift office products and supplies, up to 40 lbs.
Is desk-based and may be sitting for long periods of time.
Must regularly use fingers and hands for fine manipulation: typing, writing, using hand-held device (iPad, laptop, cell phone, keyboard, printer)
Must communicate clearly: phone calls, emails, in-person conversations
Must possess ability to make sound decisions, process complex information, manage multiple tasks simultaneously, model behavior for other employees, and other cognitive functions.

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Refine Your Search

regulatory affairs manager jobs in florham park nj

Associate Manager, Regulatory Affairs

Manager/Senior Manager, Global Regulatory Affairs

Manager, Regulatory Affairs - Tactical Implementation

Manager, Regulatory Affairs - China

Regulatory Affairs Manager

Regulatory Affairs Project Manager (173814)

Senior Regulatory Affairs Specialist

Senior Manager / Associate Director, Regulatory Affairs CMC

Project Manager, Regulatory Affairs - Project Management

Manager Regulatory Affairs

Manager, Regulatory Response

Manager, Project Management, Regulatory

Manager/Director Board Governance & Executive Affairs

Manager-CMC Manager- Regulatory Affairs

Regulatory Affairs Program Manager

US Regulatory Affairs Senior Manager – Allergy

Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)

Manager, Regulatory Affairs Packaging Compliance

Manager, Regulatory Affairs Strategy - Oncology

Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins - Hybrid

I want to receive the latest job alert for regulatory affairs manager in florham park nj

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